Effect of Thumbtack Needle (TN) on Ovarian Reserve Function of Women With Diminished Ovarian Reserve (DOR)

NCT05277948 | Completed

• 1 other identifier: Effect of TN on DOR
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Using a multi-center, large sample, randomized, patient-assessor blinded, sham-controlled clinical trial to evaluate the effect of thumbtack needle (TN) on ovarian function of patients with diminished ovarian reserve (DOR).

Conditions

Diminished Ovarian Reserve

Keywords

diminished ovarian reserve; thumbtack needle; ovarian reserve function

Outcome Measures

Primary Outcomes (2)

• Evaluating the change of serum AMH level

  Assessing patients' serum level of AMH in ng/ml at baseline (0 week) and immediately (up to 4 weeks) after treatment completion.

  0 week and up to 4 weeks after treatment completion

• Evaluating the change of the ovarian antral follicle count (AFC)

  Counting the number of ovarian antral follicle count (AFC) on the second day of menstruation at baseline (0 week) and immediately (up to 4 weeks) after treatment completion.

  0 week and up to 4 weeks after treatment completion

Secondary Outcomes (20)

• Evaluating the serum levels of sex hormones

  0 week and up to 4 weeks after treatment completion

• Natural pregnancy outcomes include natural pregnancy rate and miscarriage rate

  0 week and within 6 months after treatment completion

• Pregnancy outcomes of IVF-ET within 6 Months after Treatment Completion

  0 week and within 6 months after treatment completion

• Observing the level of transforming growth factor β (TGF β) in follicular fluid

  within 6 months after treatment completion

• Observing the level of tumor necrosis factor-α (TNF-α) in follicular fluid

  within 6 months after treatment completion

Study Arms (2)

treatment group

ACTIVE COMPARATOR

Active thumbtack needle (TN) and electro-thumbtack needle (ETN) will be used in the treatment group

Other: active TN and ETN treatment

control group

SHAM COMPARATOR

Sham thumbtack needle (TN) and sham electro-thumbtack needle (ETN) will be used in the control group

Other: sham TN and sham ETN treatment

Interventions

active TN and ETN treatment OTHER

The following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints, bilateral spleen (SP) 6, bilateral stomach (ST) 36, bilateral bladder (BL) 23 and bilateral EX-B7 will be used. Eight acupoints of CV4, CV3, SP6, ST36 and BL23 will be treated by disposable sterile thumbtack needle (TN) for single use (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM2-6YDL), and four acupoints of bilateral ovary acupoints and bilateral EX-B7 will be treated by disposable sterile electro-thumbtack needle (ETN) (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM3-ZY) with pulsed electrical stimulation. The patients will receive a treatment of 2 menstrual cycles.

treatment group

sham TN and sham ETN treatment OTHER

The acupoints used in the control group are the same as those in the treatment group. Eight points of CV4, CV3, SP6, ST36 and BL23 will be treated by the sterile sham thumbtack needle (TN) for single use (Hangzhou Zhuomai Medical Technology Co., LTD.), and four points of bilateral ovary acupoints and bilateral EX-B7 will be treated by disposable sterile sham electro-thumbtack needle (ETN) (Hangzhou Zhuomai Medical Technology Co., LTD.) with sham pulsed electrical stimulation. The sham TN and ETN used in this group are identical in appearance, shape, and color to the active TN and ETN but lack the needle body, thus lacking the needle-penetrating effect. The stimulation method and frequency for the sham ETN are the same as those of the ETN group. The only difference is that the electrode pads used in the sham ETN group are specially designed as insulated controls. The patients will receive a treatment of 2 menstrual cycles

control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with age between 18 and 40 years;
• Low ovarian reserve: AMH\<1.1ng/ml; or AFC\<7; or 10 U/L\<FSH\<25U/L or FSH/LH\>3.6; or has a history of poor ovarian response, that is, in the last controlled hyperstimulation cycle, the number of retrieved oocytes\<3. Any 2 of the above 4 conditions are met.
• Sign informed consent voluntarily.

You may not qualify if:

• Patient's chromosome is abnormal.
• Patients with previous ovarian surgery because of such as ovarian teratoma or chocolate cyst and so on.
• Patients with uncorrected endocrine disease, such as: Simple hyperthyroidism or hypothyroidism, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.
• Patients with definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Sjogren's syndrome, Hashimoto's thyroiditis.
• Patients with a history of cancer and has received radiotherapy or chemotherapy.
• Patients had the treatment of acupuncture or thumbtack needle in recent 3 months.
• Patients who take Chinese medicine decoction or granule during the treatment;
• Patients unwilling to sign the informed consent of this study.

Sponsors & Collaborators

• Dongmei Huang: lead

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Officials

• Hanwang Zhang

  Huazhong University of Science Tech

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate Professor

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: March 14, 2022
• Study Start: October 18, 2021
• Primary Completion: November 28, 2025
• Study Completion: December 6, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January, 2027, for 1 year
• Access Criteria: only for research

Locations

CN (1)